ORTHOSPHERE CERAMIC SPHERICAL IMPLANT


Device Classification Name

prosthesis, toe, hemi-, phalangeal

510(k) Number K030319
Device Name ORTHOSPHERE CERAMIC SPHERICAL IMPLANT
Original Applicant
WRIGHT MEDICAL TECHNOLOGY, INC.
5677 airline rd.
arlington, 
TN 
38002

Original Contact katie logerot
Regulation Number 888.3730
Classification Product Code
KWD  
Date Received 01/30/2003
Decision Date 11/26/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No